We conducted a brief, Web-based survey of MSM enrolled in an ongoing, blinded vaccine efficacy trial that offered a valuable snapshot of their interest in PrEP shortly after the iPrEx results were released. Our study showed that less than a fifth of respondents reported they would be very likely to take PrEP in the coming year. However, more than half expressed strong interest in taking PrEP if it were provided through the trial or were available through their health care providers and covered by insurance. Notably, participants from communities of color were more likely to express intent to use PrEP. In addition, we found that PrEP would minimally influence enrollees’ willingness to remain in HVTN 505 and that they believed it would be unlikely to hamper study recruitment.
To date, few studies nested within ongoing HIV prevention trials have assessed the perspectives of currently enrolled participants about emerging HIV prevention technologies, and as far as we are aware, none have produced results that directly influenced the design of the ongoing trial. In 2011, the sample size of HVTN 505 was expanded from 1350 to 2200 participants. This new enrollment target accounted for a conservative estimate of 20% PrEP uptake gleaned from our survey and, informed by the promising RV144 trial results,11 increased the statistical power to detect an impact on HIV acquisition and early viral load setpoint. Survey data supplemented the substantial input sought from community stakeholders that led to the decision to offer education about PrEP to study participants and to include active behavioral and biologic monitoring of PrEP use in the vaccine trial. In addition, the study team is working closely with trial sites to ensure community providers can accommodate referred participants interested in PrEP and that HIV test results obtained at the site are readily shared with these providers to avoid misdiagnosis of HIV infection or unblinding to treatment assignment from vaccine-induced seropositivity.
Although the stated willingness to use PrEP was modest in the months following the release of the iPrEx results, we recognize that demand for PrEP may evolve over time. This study and others10 have found that interest in PrEP use was affected by many contextual factors including perceptions about accessibility and cost. Since the survey went into the field, the U.S. Centers for Disease Control and Prevention released interim guidance on PrEP,12 and new trial data were released in the summer of 2011 establishing the safety and efficacy of TDF/FTC in other populations including serodiscordant couples and at risk heterosexuals.3,4 On July 16, 2012, the U.S. Food and Drug Administration approved TDF/FTC to be taken daily as PrEP in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk.13 This new prevention indication is likely to spur both private and public insurers to cover the costs of PrEP.14 In addition, government-funded PrEP demonstration projects are being initiated or planned in several U.S. cities, which may increase access for some communities.
This study has some limitations. Participants represent a convenience sample of current HVTN 505 enrollees seen in the months following the release of the iPrEx results, which may not reflect the perspectives of the entire cohort nor be generalizable to all MSM and TG communities at risk. This limitation is mitigated to a reasonable extent by the innovation of surveying participants shortly after the release of a major clinical research result and the desire for the study team to get valuable input from its enrollees, which guided how HVTN 505 adapted to the iPrEx results. In addition, we may have underestimated the intent to take PrEP or to remain in the vaccine trial as some respondents may have been reluctant to disclose their interest in PrEP, believing it could threaten their ability to remain in the trial. We tried to reduce social desirability bias through the use of an anonymous, Web-based survey and by reinforcing with our study volunteers that the decision to use PrEP would not in any way preclude continued involvement in the trial. Finally, several potential correlates of interest were not measured in this study, such as sexual risk behaviors, which have been shown to predict willingness to use PrEP.10 Planned analyses will consider these correlates in the assessment of actual PrEP use in HVTN 505.
These analyses reinforce the need for reliable mechanisms to access PrEP at low or no cost, particularly for minority American MSM.15–17 PrEP availability in these communities should be prioritized. Although increased access may enhance PrEP uptake, providers have identified a number of challenges to PrEP implementation in clinical settings, including the need for additional training and definitive guidance from normative bodies.18 Furthermore, ongoing community concerns about adherence, risk compensation, viral resistance, and longer-term safety will likely influence the demand for PrEP as we await prospective data from open label studies.19,20 As our understanding of these issues continue to evolve, we have shown that it is feasible, and desirable, to gather input systematically from actively enrolled trial participants about new HIV prevention strategies.
This input can directly inform changes to the trial’s design and conduct. It is an exciting and increasingly complex time in HIV prevention science as we determine how best to incorporate new tools to limit the spread of HIV. Future HIV vaccine trials, such as prevention trials investigating other modalities, must thoughtfully consider these advances as researchers iteratively reevaluate the standards of prevention.21 Emerging data should be bolstered by effective and transparent engagement with key stakeholders, including trial participants.
The authors thank Dr. Albert Liu for his helpful comments on an early draft of this article. In addition, they would like to gratefully acknowledge the study participants and the work and contributions of HVTN 505 trial site staff and community advisory boards.
HVTN 505 Protocol Team and Clinical Research Site Investigators (in addition to named authors):
Annandale, MD—Donald Poretz; Atlanta, GA—Mark Mulligan, Sri Edupunganti; Bethesda, MD—Barney Graham, Julie Ledgerwood; Birmingham, AL—Paul Goepfert; Boston, MA—Lindsey Baden, Doug Krakower; Chicago, IL—Richard Novak; Cleveland, OH—Michael Lederman, Benigno Rodriguez; Dallas, TX—Mamta Jain; Denver, CO—Thomas Campbell; Houston, TX—Hana El Sahly; Los Angeles, CA—Stephen Brown; Nashville, TN—Spyros Kalams; New York, NY—Demetre Daskalakis; Orlando, FL—Edwin DeJesus; Philadelphia, PA—Ian Frank; Rochester, NY—Michael Keefer; San Francisco, CA—Susan Buchbinder, Darpun Sachdev; Seattle, WA—Juliana McElrath, Janine Maenza; HIV Vaccine Trials Network—Soyon Im, Jim Maynard, Niles Eaton, Steve Wakefield, Shelly Mahilum, Peter Gilbert, Jim Kublin, Larry Corey; National Institute of Allergy and Infectious Diseases—Elizabeth Adams; and Community representatives—Rick Church, Richard Trevino, Jason Roberts, Coco Alinsug.
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Keywords:© 2013 Lippincott Williams & Wilkins, Inc.
clinical trials; HIV vaccines; HIV prevention; preexposure prophylaxis; good participatory practice